Laboratorio Medico

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records and laboratory director interview, it was determined that laboratory failed to evaluate and monitor the General Laboratory system requirements since January 2022. The findings include: a. On December 20, 2022 at 9:50 AM, the laboratory QA was requested. No QA record was available. b. Since January 2022 the laboratory did not evaluate practices related to: Patient confidentiality, specimen identification and integrity, compliant investigation, communications and personnel competency. c. The laboratory director confirmed on December 20, 2022 at 9:50 AM that the general laboratory system QA evaluation were not available. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records and laboratory director interview, it was determined that laboratory failed to evaluate and monitor the pre- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- analytic systems requirements since January 2022. The findings include: a. On December 20, 2022 at 9:50 AM, the laboratory QA was requested. No QA record was available. b. Since January 2022 the laboratory did not evaluate practices related to: test request, specimen submission and handling, specimen referral. c. The laboratory director confirmed on December 20, 2022 at 9:50 AM that the pre-analytic systems QA evaluation were not available. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Syphilis Serology (Rapid Plasma Reagin (RPR)) quality control records review (years 2021 to 2022) and interview with the laboratory director, it was determined that the laboratory did not include each day of testing the reactive nor the non reactive control materials when 11 out of 11 patients specimens were tested and reported for RPR on September 7, 2022. The findings include: 1. The laboratory use Immunostic RPR Card testing method to perform the Syphilis qualitative test. 2. On December 20, 2022 at 8:50 AM, review of syphilis quality control record showed that the laboratory did not include each day of testing the reactive nor the non reactive control materials on September 7, 2022. 3. The laboratory director confirmed on December 20, 2022 at 9:06 AM, that the laboratory failed to include each day of patient testing the reactive and non reactive control material on September 7, 2022. 4. The laboratory processed and reported 11 out 11 patient samples for Syphilis (RPR) qualitative tests without controls on September 7, 2022 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records and laboratory director interview, it was determined that laboratory failed to evaluate and monitor the analytic systems requirements since January 2022. The findings include: a. On December 20, 2022 at 9:50 AM, the laboratory QA was requested. No QA record was available. b. Since January 2022 the laboratory did not evaluate practices related to: test procedures, accurate and reliable test system, equipment, instruments, reagents, materials, specimen and reagent storage conditions, system maintenance and function checks, verification of method performance specifications, calibration, control procedures, comparison of test results, test records, corrective ations. c. The laboratory director confirmed on December 20, 2022 at 9:50 AM that the analytic systems QA evaluation were not available. -- 2 of 3 -- D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records and laboratory director interview, it was determined that laboratory failed to evaluate and monitor the post- analytic systems system requirements since January 2022. The findings include: a. On December 20, 2022 at 9:50 AM, the laboratory QA was requested. No QA record was available. b. Since January 2022 the laboratory did not evaluate practices related to: test report and turn around time. c. The laboratory director confirmed on December 20, 2022 at 9:50 AM that the post-analytic systems QA evaluation were not available. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Syphilis Serology (RPR (rapid reagin plasma)) quality control records review, and interview the laboratory director on December 20, 2022 at 10:15 AM, it was determined that the laboratory director failed to follow the quality control procedures for the RPR. Refer to D 5449. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of Quality Assesstment (QA) records and laboatory director failed to evaluate and monitor the QA requirements. Refer to D5291, D5391, D5791 and D5891. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of Puerto Rico Proficiency Testing records in years 2017-2018 and laboratory director interview at 11:00 AM on December 12, 2018, it was determined that the laboratory failed to maintain Proficiency Testing events records. The findings include: 1. Puerto Rico Proficiency Testing records were reviewed from January 2017 to December 2018. 2. Review of proficiency testing records showed that the laboratory did not maintain the proficiency testing events records from January to December, except the second event for routine chemistry (June 2018). 3. The laboratory director confirmed on December 12, 2018 that the laboratory did not maintain these proficiency testing event records. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of Puerto Rico Proficiency Testing records in years 2017-2018 and laboratory director interview at 11:00 AM on December 12, 2018, it was determined that the laboratory failed to keep Proficiency Testing records for at least 2 years. Refer to D3037 (the laboratory failed to retain proficiency testing records for at least 2 years). D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Puerto Rico Proficiency Testing records in years 2017-2018 and laboratory director interview at 11:00 AM on December 12, 2018, it was determined that the laboratory failed to retain proficiency testing records for at least 2 years. The findings include: 1. Puerto Rico Proficiency Testing records were reviewed from January 2017 to December 2018. 2. The laboratory did not have available the proficiency testing records documentation from January 2017 to December 2018, only the laboratory had the second event of routine chemistry (June 2018). 3. The laboratory director confirmed on December 12, 2018 at 11:00 AM that the laboratory did not have available the Proficiency Testing records since January 2017 to December 2018, except the second event of routine chemistry (June 2018). D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on lack of Puerto Rico Proficiency Testing records in years 2017-2018 and laboratory director interview at 11:00 AM on December 12, 2018, it was determined that the laboratory failed to keep Proficiency Testing records for at least 2 years. Refer to D3000 (the laboratory failed to retain proficiency testing records for at least 2 years). -- 2 of 2 --